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Whereas monoclonal antibody therapy has been a mainstay of lymphoma regimens for many years, the development of these agents has lagged for multiple myeloma.
To test the efficacy and safety of the anti-CD38 monoclonal antibody daratumumab in multiple myeloma, investigators conducted an industry-sponsored, multinational, randomized, phase II trial involving 106 patients with relapsed disease that was refractory to both proteasome inhibitors and immunomodulatory agents. Most patients (80%) had received prior high-dose therapy and autologous stem cell transplantation, and 97% were resistant to their most recent treatment. Patients received a dose of 16 mg/kg weekly for 8 weeks, then biweekly for16 weeks, and then once every 4 weeks until diseas…